Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg
[Schering AG, Report No. X331 -draft-, 1998-12-21]
Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg
[Schering AG, Report No. X324 -draft-, 1998-11-05]

Key value for chemical safety assessment

Additional information

The single oral administration of the test substance (ZK 90504) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality and compound-related clinical or macroscopic pathological signs. The acute oral toxicity of Enpivalat in rats is above 2000 mg/kg body weight.

The single dermal administration of the test substance (ZK 90506) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or macroscopic pathological signs. Shortly after administration females showed some clinical signs such as hyperactivity, vocalization and spastic gait. No compound-related clinical signs were observed in females from 3 hours after administration onwards, males were without findings over the whole study period. The acute dermal toxicity of Enpivalat in rats is therefore above 2000 mg/kg body weight.

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.

Categories Display